When it comes to critical environments like laboratories, a NEBB Certified Professional (CP) does more than testing, adjusting and balancing (TAB), building systems commissioning (Cx), fume hood performance testing (FHT), or cleanroom performance testing (CPT) work. Long after conducting the steps outlined in NEBB’s procedural standards, including the submission of test reports to the client with results and recommendations, the unique perspective and experience of a NEBB CP continues to help owners ensure their facilities meet codes and standards while keeping workers safe.
However, safety in critical environments like laboratories is truly a combined effort. Whether the laboratory exists to support life sciences work, higher education research, or pharmaceutical manufacturing, all parties involved are responsible for establishing a safe environment. Owners, designers, NEBB professionals, and lab personnel each play an important and distinct part in creating and maintaining the safest possible working conditions for their specific laboratory environment.
Designing for Safety
Beginning with end users in mind, lab owners take precautions to ensure the safety of their environment for workers both before and during construction of the lab itself, as well as once the lab is up and running.
Some of these precautions include calculating the maximum volume of materials to be stored or handled in the lab so that in the event of an accidental release, adequate airflow is ensured to protect the worker, even in a worst-case scenario. Setting up lab protocols and procedures to handle smaller quantities of hazardous chemicals can also help scale down the potential of a hazardous event.
For example, Vice President and COO of the Institute for In Vitro Sciences, Hans Raabe, who is focused on product research and safety testing, explains, “We’re working with cell cultures to replace traditional safety tests conducted in animals, so the amount of test materials needed for our test methods is around one-hundredth to one-thousandth of what’s needed for typical animal testing. By using 96-well microtiter plates the size of a three by five-inch card, each of the replicate wells can be analogous to replicate animals used in a test, but in downsizing to the cellular or tissue level, each well only uses nanogram to milligram quantities of hazardous material versus the much larger quantities required for actual animal testing.”
“We planned for worker safety in the facility design. Prior to opening the new lab, we worked with a contractor to check the performance of the biosafety hoods and verify airflow design,” Raabe continues. “And we have the performance of the hoods certified by the contractor at least annually.”
Mechanical engineers like Associate/Mechanical Technical Leader of Henderson Engineers Kelley Cramm, PE, play an important role in designing lab environments like the one described above. Cramm attests to the importance of engaging a NEBB CP by asserting, “It’s important for designers to cultivate and maintain relationships with local NEBB professionals because they can be a great resource. As the designer, I often enlist the balancer and commissioning agent as a partner because they understand a lot about a project, whether systems are operating correctly or if there’s a risk for exposure. They’re the ones doing the hands-on work and have a different experience than I do, which is valuable to me as an engineer.”
“When a NEBB CP is hired by the owner directly and early on, they are really able to become part of the team. They then have the necessary background info and understand the intent of the project. In my experience, at least in this part of the country around Kansas City, I wouldn’t work with anyone but a NEBB Certified Professional,” she continues.
Proper Training and Protective Gear
Another essential precaution taken by owners to ensure safe procedures are followed in the lab is personnel training. This can include teaching employees to adhere to strict gowning requirements, as well as following the proper order of procedures in the lab and ensuring everyone knows the step-by-step requirements for working safely in that particular environment.
“We have training and standard operating procedures in place for how a worker needs to work in the laboratory as well as in the biosafety cabinets. They learn to gown up and wear personal protective equipment like gloves, eye protection, and, in some instances, half-face respirators; they learn to wipe down the interiors of the biosafety cabinets both to protect themselves as well as the cell cultures and then they clean down the hood again after the work is done,” explains Raabe.
Training also takes place before a NEBB CP enters the lab. Oftentimes, the NEBB CP watches a video provided by the owner to learn the proper sequence of protocols and procedures taking place in the lab day in and day out. That training ensures the NEBB professional can follow the exact sequence when performing the necessary testing to determine whether or not the work taking place in the lab, as well as the systems and equipment making up the lab, are up to codes and standards.
In some situations, the observations of a NEBB CP may even lead to an altered order of the steps being taken to execute the work if they can identify that a different sequence offers lab personnel a safer manner in which to do their work. Likewise, if the NEBB professional is taught that steps should be executed in one order through the training but then encounters personnel in the lab performing the tasks in a different order, it is their job to note it in the report.
“The training and personal protective gear we provide is intended to ensure anyone that will enter the lab has the proper knowledge and tools to protect themselves and their coworkers while they’re engaged in activities, as well as to ensure the integrity and sterility of the cell cultures and associated materials” states Raabe.
“Gowning up properly keeps us from the environment and the environment from us,” adds CEO of IND Analytical Tiffany Russell, a NEBB CPT Certified Professional who frequently works in pharmaceutical and life sciences lab environments. “Clear communication with the customer is also really important. We rely on the customer to outline their processes and to display the appropriate signage showing hazards. That helps NEBB CPs become hyper-aware of the dangers specific to that environment.”
Staying Alert and Aware in the Lab Environment
Following training, even employees with vast experience in that lab must stay on high alert in order to maintain safety in a hazardous environment. Regardless of the type of lab, it is vital for lab personnel to mentally walk through the steps they are about to take to ensure the processes can be done well and done safely.
“Pre-study planning the steps or creating a mental prototype of what you’re going to do can go a long way in terms of safety,” offers Raabe. “Things like proactively checking the meters and gauges on the laminar flow hoods to ensure air is flowing properly, rather than only relying on the airflow alarm systems installed during construction of the lab, add another layer of protection for workers. Laboratory safety should be foremost in the worker’s agenda; people can’t become complacent.”
The same goes for a NEBB CP entering a lab environment to perform testing. Before testing can commence onsite, a NEBB CP is required to perform a job hazard analysis per NEBB procedural standards. Evaluation of the site and what is being asked of the NEBB CP prior to the onset of work inside the lab helps to ensure client requests are possible and can be executed safely.
Once onsite, Russell recommends, “If something looks questionable, stop what you’re doing immediately. Go with your gut and go ask for help.” Knowing it is imperative to one’s personal safety to keep an eye out for anything that looks off, she continues, “If you see a puddle of liquid on the floor, don’t assume it’s water. Question everything! Be aware, be alert, and treat everything as a potential hazard. It’s the safety of your team and end users on the line.”
Owner Education and Ongoing Testing
Certain precautions undoubtedly help owners maintain a safe environment that meets requirements—but that is only possible when the owner knows the applicable codes and standards for their facility.
“Someone who can help educate the owner is always helpful. Some owners may not know that they need to get someone to test the fume hood and calibrate the alarm annually,” explains Cramm. “An owner needs an ongoing relationship with a NEBB Professional.”
“We need to be sure that airflow, pressurization, supply air, and exhaust are all functioning as they were designed to in that lab. If a designer didn’t set up the lab to be negative or if the lab is recirculating air, those things need to be noted in the NEBB CP’s report,” says Cramm. “Depending on who has hired the NEBB CP for that facility, they can be put in a somewhat delicate position, but by simply listing items that do not meet requirements as observations and giving the owner a chance to correct things that need to be corrected, safety can be maintained.”
“NEBB CPs can make recommendations back to the customer on products we use—especially if there’s something more appropriate for the task. It’s part of why we’re hired,” mentions Russell.
Knowledge of Applicable Codes and Standards
Although regulations vary with each industry a given lab is intended to serve, it is always advisable for NEBB CPs to familiarize themselves with codes and standards that may be relevant to their clients’ lab environments. NEBB’s procedural standards already require NEBB CPs to perform a series of stringent tests that have been extrapolated from various sources, but NEBB professionals must also get to know the specific codes and standards outlined for each unique client’s lab to test properly and ensure it meets the specified requirements.
Some common codes and standards relevant to different types of lab environments include:
- American National Standards Institute (ANSI) Z9.5 Laboratory Ventilation Standard: Outlining laboratory ventilation requirements and practices, this standard covers performance tests, air cleaning, preventive maintenance, and work practices. It is intended to help inform designers of ventilation guidelines that can be used to achieve acceptable concentrations of air contaminants and can also prove useful for lab management personnel.
- ASHRAE 110 Methods of Testing Performance of Laboratory Fume Hoods: Intended primarily for laboratory and factory testing, this method of testing applies to conventional, bypass, auxiliary air, and variable-air-volume (VAV) laboratory fume hoods. Designers and NEBB CPs likely know this standard from its frequent appearance in project specifications and use as an aid in evaluating installed performance.
- ISO 14644-1:2015 Cleanrooms and associated controlled environments, Part 1: Classification of air cleanliness by particle concentration: Focusing on professionals who deal with controlled environments, this standard specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones, as well as separative devices.
- National Fire Protection Association (NFPA) 45: Standard on Fire Protection for Labs Using Chemicals: This standard provides basic requirements to protect life and property through the prevention and control of fires and explosions involving the use of chemicals in laboratory-scale operations. By building control hazards into lab operations, the potential effects of chemical exposure during a hazardous event are designed to prevent injury or death to occupants and emergency response personnel.
- NSF International Standards: As an organization dedicated to developing standards and criteria for health-related equipment, products, and services, NSF serves as a resource for manufacturers, regulators, and consumers looking to protect food, water, consumer products, and environments.
- Occupational Safety and Health Administration (OSHA) Laboratory Safety Guidance: Most relevant to the employer or lab owner in terms of maintaining a safe environment for workers, OSHA guidelines cover lab design, equipment, and ventilation systems. More specifically, these standards require the availability and maintenance of safety equipment, measures to control the risk of exposure to chemical hazards or biological specimens by employees of the lab testing facility, sanitary condition of the testing lab, annual inspections, a waste management program, procedures for infectious material response, ventilation failure, first aid, fires, and emergencies, as well as documentation of all spills and exposure incidents.
- Scientific Equipment and Furniture Association (SEFA) Recommendations: Created to meet the needs of lab designers and manufacturers of laboratory furniture, these recommended practices help manufacturers avoid liability while also ensuring safety for clients by minimizing risk due to poor ventilation or operation of fume hoods and lab equipment.
- United States Pharmacopeia (USP) General Chapter <797> Pharmaceutical Compounding – Sterile Preparations: By developing standards for preparing compounded sterile medications, USP standards help reduce risks to the patient such as contamination, infection, or incorrect dosing. This standard helps outline the risks inherent in sterile compounding and ensure compounded medications are not sub-potent, super potent, or compromised.
Whether a NEBB CP has two years or twenty-two years of experience working in a lab environment, it is important to brush up on regulations and fully understand the intent of the lab’s operations. Russell suggests, “Read the project specifications and applicable codes and standards and talk to other NEBB professionals in our network if you have any questions. Reach out. It’s a network we have available to us, so we should use it.”
“At the end of the day, we all want to make the lab safe for those working in it,” sums up Cramm. Together, the designer and project team can use best practices to create a safe lab environment, and lab personnel can maintain safety through proper training, but it is the ongoing dedication of the owner to engage NEBB professionals that ultimately results in meeting standards and achieving safety success.
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